FDA.reportPublic FDA data

EPIONE RoboKit

Primary DI
03760305400260
Brand
EPIONE RoboKit
Company
QUANTUM SURGICAL
Model
09-0057
Device description
The EPIONE® RoboKit™ is used during the CT guided procedures performed with EPIONE®.Sterile drapes are used to cover: the robotic arm, the touchscreen of the display cart, the tray of the display cart supporting the mouse and the keyboard. Reflective spheres to be placed on the tracked EPIONE instruments tracked.
Published
2024-12-12
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
LROGeneral Surgery Tray

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LROGeneral Surgery TrayGeneral, Plastic Surgery2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
03760305400260PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
03760305400260037603054002603760305400260

GMDN Terms#

Term, Definition table
TermDefinition
Surgical optical-tracking spatial marker, single-useA non-powered, noninvasive component of a surgical navigation and/or device tracking system (e.g., computer-assisted surgical ultrasound system, surgical microscope) intended for preoperative and/or intraoperative use to function as an optical reference to enable spatial registration/tracking of the position/movement/size of a patient, another marker and/or surgical instrument (e.g., stereotactic surgery probe). It may be attached to the patient, another marker or surgical instrument, and may contain features (e.g., reflective spheres, contrast patterns) detectable by a tracking camera. Procedural supportive devices (e.g., drapes) may be included with the device. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
268397609
Device count
1
Premarket exempt
true
Kit
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
03760305400031EPIONE30-0001 v1.0.22023-05-25
03760305400024Patient Reference02-002602-00262022-09-09
03760305400055Navigation probe02-003102-00312022-09-09
03760305400062Needle Guide02-002702-0027-19G2022-09-09
03760305400079Short Navigation Probe02-004402-00442022-09-09
03760305400086EPIONE30-0001 30-0001-01-USA2022-09-09
03760305400253EPIONE RoboKit Plus09-00462024-12-06

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
B098AMS17798A0Aligned Medical SolutionsAligned Medical SolutionsLRO2026-07-26
B098AMS179150Aligned Medical SolutionsAligned Medical SolutionsLRO2026-07-26
B098AMS190180Aligned Medical SolutionsAligned Medical SolutionsLRO2026-07-26
B098AMS190730Aligned Medical SolutionsAligned Medical SolutionsLRO2026-07-26
B098AMS190920Aligned Medical SolutionsAligned Medical SolutionsLRO2026-07-26
B098AMS190930Aligned Medical SolutionsAligned Medical SolutionsLRO2026-07-26
B098AMS194550Aligned Medical SolutionsAligned Medical SolutionsLRO2026-07-26
B098AMS195260Aligned Medical SolutionsAligned Medical SolutionsLRO2026-07-26
B098AMS13932C0Aligned Medical SolutionsAligned Medical SolutionsLRO2026-07-25
B098AMS16019B0Aligned Medical SolutionsAligned Medical SolutionsLRO2026-07-25
B098AMS17843A0Aligned Medical SolutionsAligned Medical SolutionsLRO2026-07-25
B098AMS18256A0Aligned Medical SolutionsAligned Medical SolutionsLRO2026-07-25
B098AMS187260Aligned Medical SolutionsAligned Medical SolutionsLRO2026-07-25
B098AMS5861D0Aligned Medical SolutionsAligned Medical SolutionsLRO2026-07-25
10809160527825HalyardAVID MEDICAL, INC.LRO2026-07-24
10809160527788HalyardAVID MEDICAL, INC.LRO2026-07-23
10809160527801HalyardAVID MEDICAL, INC.LRO2026-07-23
10809160527818HalyardAVID MEDICAL, INC.LRO2026-07-23
10809160527726HalyardAVID MEDICAL, INC.LRO2026-07-22
10809160527733HalyardAVID MEDICAL, INC.LRO2026-07-22
10809160527740HalyardAVID MEDICAL, INC.LRO2026-07-22
B098AMS15343A0Aligned Medical SolutionsAligned Medical SolutionsLRO2026-07-22
B098AMS174900Aligned Medical SolutionsAligned Medical SolutionsLRO2026-07-22
B098AMS187270Aligned Medical SolutionsAligned Medical SolutionsLRO2026-07-22
10653160394068CENTURIONCENTURION MEDICAL PRODUCTS CORPORATIONLRO2026-07-21
10653160394105MEDLINEMEDLINE INDUSTRIES, INC.LRO2026-07-21
10653160394150MEDLINEMEDLINE INDUSTRIES, INC.LRO2026-07-21
10653160394167MEDLINEMEDLINE INDUSTRIES, INC.LRO2026-07-21
10653160394174MEDLINEMEDLINE INDUSTRIES, INC.LRO2026-07-21
10653160394266MEDLINEMEDLINE INDUSTRIES, INC.LRO2026-07-21